Skip to content

A multi-disciplinary teams’ collaborative approach to transition mepolizumab dependent severe eosinophilic asthmatic patients to self-administration in response to the COVID-19 pandemic

Pdf

PDF Icon

European Statement

Clinical Pharmacy Services

Author(s)

Grainne D’Ancona, Niall Stewart-Kelcher, Schaya Bains, Andrew Hearn, Joanne Kavanagh, Cris Roxas, Linda Green, Louise Thomason, Marianna Fernandes, Brian Kent, Alexandra NanzerKelly, David Jackson, Jaideep Dhariwal

Why was it done?

The COVID-19 pandemic necessitated the rapid transition of the remaining 41 mepolizumab dependent SEA patients onto home administration to facilitate on-going therapy in a cohort of patients who were “shielding” under UK government guidance.

What was done?

87 severe eosinophilic asthmatic (SEA) patients treated with mepolizumab; a biologic agent targeting interleukin-5 (IL-5), at a specialist NHS asthma clinic, were transferred to self-administration at home compared to usual practice of administration in a hospital setting. 40 patient were transferred in late 2019 as a planned ‘pilot’ transition and 47 patients were transferred unplanned due to the COVID-19 pandemic. We investigated whether there was a change in asthma control following the transition to home administration and whether a differential response to treatment exists following transition to homecare before and after the onset of the COVID-19 pandemic.

How was it done?

A varied multi-disciplinary team including pharmacists, pharmacy technicians, specialist nurses, doctors, physios and phycologist conducted a variety of in-person and virtual (telephone and video) consultations to consent and train patients on self-administration in their own homes in a rapid transfer to home administration

What has been achieved?

Patients receiving mepolizumab at home were stratified according to those who had a planned transition prior to 1st Feb 2020 versus those who had an unplanned transition after this date necessitated by the COVID-19 pandemic. The last Asthma Control Questionnaire-6 (ACQ6) measured in clinic (“baseline”) was compared with that collected by telephone consultation 6-8 weeks after transition. Immediately prior to transition to homecare (baseline), the planned group had a lower mean ACQ6 than those in the unplanned group (1.19 vs 1.90, P=0.004). The ACQ6 on home administration decreased significantly in both groups (-0.47 in the planned group vs -0.56 in the unplanned group, both P<0.001). The ACQ6 for the planned cohort during homecare was significantly lower than that for the unplanned group (0.72 vs 1.34, P=0.012).

What next?

Evaluation of patient experience on the switch to home administration is currently being carried out via patient surveys with this to be completed in early 2021. Further research is required to understand the potential influence of lockdown and/or telephone vs face-to-face ACQ reporting.

USE OF LINKED DATA SOURCES IN DYNAMIC DASHBOARDS TO VISUALISE HOSPITAL PRACTICE DIFFERENCES IN MEDICATION USE AND OUTCOMES

Pdf

PDF Icon

European Statement

Patient Safety and Quality Assurance

Author(s)

Rawa Ismail, Jesper van Breeschoten, Michel Wouters, Anthonius de Boer, Alfonsus van den Eertwegh, Maaike van Dartel, Caspar van Loosen, Doranne Hilarius

Why was it done?

Most drugs obtain approval based on limited numbers of highly selected patients and mostly surrogate outcomes. Little is known on hospital variation on the use of new treatments in daily clinical practice. Benchmark information can be used to limit between hospital variation and provides real world evidence on the value of these treatments.

What was done?

In the Dutch Institute for Clinical Auditing (DICA) medicines project, administrative data on the use of expensive drugs from hospital pharmacies were linked to clinical data from national quality registries and hospital declaration data. Data were visualised in six dynamic dashboards (lung cancer, breast cancer, rheumatic disorders, colorectal cancers, gynaecological cancers and metastatic melanoma), leading to insight into expensive drugs use and clinical outcomes in real-world practice.

How was it done?

The three data sources were linked using patient-specific data and provide real-world insights in anti-cancer drug use and outcomes. After linkage, data were validated by individual sessions with hospital pharmacists and medical specialists.

What has been achieved?

Hospital pharmacists and medical specialists gained insight into expensive drugs use and treatment patterns in patient groups, compared to other hospitals. The dashboards also contain information on outcomes such as toxicity, emergency admissions, time-to-next treatment and users receive signals when their use of expensive medicines deviates from the benchmark. An example of the information provided by the dashboards was the number of stage IV non-small cell lung cancer patients treated with only one or two gifts of pembrolizumab. All hospitals received a report on this subpopulation to improve their treatment approach. Other findings were differences in the adjuvant treatment of stage III colon carcinoma patients and the treatment duration of trastuzumab/pertuzumab as adjuvant treatment in breast cancer patients.

What next?

The DICA medicines project is an example of good practice as it reuses available data sources without any additional registration burden. In the future, the dashboards will be extended with survival data and PROMs data. The focus of the program in the next year will be to include all hospitals in the Netherlands and to extend the dashboards with more features.

DEVELOPMENT OF AN IT TOOL TO ESTIMATE THE THERAPEUTIC NEEDS OFHOSPITALISED PATIENTS WITH COVID19 INFECTION BASED ON SIR EPIDEMIOLOGICALMODEL

Pdf

PDF Icon

European Statement

Selection, Procurement and Distribution

Author(s)

Daniele Leonardi Vinci, Adriano Meccio , Alessio Provenzani, Piera Polidori

Why was it done?

The COVID 19 pandemic unprecedently challenged National Health Services to assure adequate patient care, despite a constantly escalating drugs demand. This complex situation requires appropriate planning to avoid misleading estimations, which would have consequences on patients and overall resources available.

What was done?

We created a tool to perform a timely estimation of the drug needs to treat the COVID-patients based on epidemiological forecasting.

How was it done?

The tool’s epidemiological forecasting was based on a compartmental model in which the population is divided into three compartments (Susceptible-Infectious-Removed, SIR), and transmission parameters are specified to define the rate at which persons move between stages. The appropriate data entry was guaranteed by the creation of a form in which users can enter information regarding: The population considered, the R0 calculation, the number of already known infected cases, the application of Non-Pharmaceutical Interventions and the number of hospital beds. The drugs need for the forecasted patients was calculated according to a list of critical care drugs compiled consulting previous published scientific works, national and international guidelines. The list includes 51 drugs belonging to different therapeutic group, such as: antiarrhythmics, antibiotics, antipyretics, antivirals, heparins, IV-fluids, local anesthetics, neuromuscular blockade agents, sedative agents and vasopressors. For each drug it was estimated the percentage average ICU uptake for therapeutic group and active principle.

What has been achieved?

A tool consisting of an excel template, that, based on the information inserted, automatically calculate the number of patients classified by the intensity of care (hospitalized not-ICU, Hospitalized ICU, ventilated, intubated or with shock) and creates a table that includes, for each drug to be used, the following information: therapeutic group, active principle, dosage considered, pharmaceutical form, total dosage for patients considered and total quantity of unit doses for patients considered. The tool is also made adaptable to different clinical situations, through the possibility of editing the assumptions adopted regarding the epidemiological and therapeutical parameters or the inclusion of new items in the drugs list.

What next?

Our tool represents an opportunity for the immediate and efficient estimation of the drugs necessary to assist the COVID19 patients during emergency scenarios. It will be periodically updated as new evidences will be available.

Horizon Scanning in Denmark: Providing the health care system with an overview and impact estimation of new medicines

Pdf

PDF Icon

European Statement

Selection, Procurement and Distribution

Author(s)

Helle Brauner

Why was it done?

There was a need for improved planning and preparing processes, as when it comes to price negotiations and estimates on financial burden and strategic procurement.

What was done?

Amgros, a part of the Danish health care system, has secured the supply of medicines and hearing aids to public hospitals and hearing clinics across Denmark for 30 years. This is done through efficient procurement and tendering procedures, creating economies of scale and savings.

In addition to this, in January 2017, Amgros launched its own Horizon Scanning unit. Now, the Danish Horizon Scanning system provides the health care system with an overview of medicines, indications and extensions e.g. pharmaceutical forms expected to be entering the Danish market within the next 2-3 years.

How was it done?

In 2016, it was decided to establish an Horizon Scanning system in Denmark. Then, input from internal and external stakerholders regarding their needs and expectations were gathered.

The outputs from the Horizon scanning unit consist of an overview of medicines about to reach the Danish market, as well as estimates of costs for new, expensive medicines and possible savings, for example if there are cheaper biosimilar drugs on the market. We also assess potential patient population and location of treatment. This is done in close cooperation with several Danish clinicians.

Sources for verifying and validating the data inputs are primarily EMA, complemented with commercial databases and a niche group of other sources. Data is gathered in a database.

What has been achieved?

The outputs enable our stakeholders to better plan the introduction of new medicines, to secure more cost-effective health solutions for everyone and to achieve more health for money in the Danish hospital setting.

Danish Regions, the interest organization for the health care regions, use the estimates in their annual negotiations with the Government on finances and the individual regions use them in their own budgets.

The predictability this system brings to Denmark is key in a future with more rare diseases, treatments and advanced pricing.

What next?

The Horizon scanning function is continuously being developed to meet the needs of our stakeholders, as we want to enable them in providing health care to the Danish citizens.

THE APPLICATION OF AN EHEALTH MODEL IN THE HEALTH CARE SYSTEM

Pdf

PDF Icon

European Statement

Clinical Pharmacy Services

Author(s)

MAR GOMIS-PASTOR, ANNA DE DIOS LÓPEZ, MARIA ANTONIA MANGUES, MIRIAM ORS, MERITXELL CUCALA, CATERINA SANPOL, VICTOR ROBERT, XAVIER BORRAS, GEMMA CRAYWINCKEL

Why was it done?

HTP are therapeutically complex patients who may benefit from an intensive telematic follow-up. Moreover, human relations among patients and health providers may be enhanced to improve patients’ empowerment with their health care. Additionally, interdisciplinary eHealth projects lead to increased interaction among health providers, expanding advanced patient-centered care in healthcare systems.

What was done?

An eHealth program directed to heart transplant patients (HTP) was implemented. The software developed was called mHeart and consists on a mobile phone application complemented by a website(https://n9.cl/ajut). A pilot study to validate the software and a clinical trial were conducted. This tool is now extended into clinical practice.

How was it done?

This project and its potential scalability has achieved the creation of a well-established framework involving among relevant others the Legal Department, the Information Systems Department, the patient data protection supervisor, and the Innovation Research Institute.
The success and the scalability of these innovative projects in our centre depended on health providers’ engagement with eHealth, new interoperability solutions, adequate institutional support, and government reimbursement models.

What has been achieved?

The clinical trial conducted in 134HTP has demonstrated to improve recipients’ adherence to immunosuppressants (85% mHeart follow-up vs 46% conventional follow-up)[OR=6.7 (2.9;15.8),P-value=.000], to improve patients’ experience of therapeutic regimens and to reduce in-clinic facilities because the mHeart follow-up. (65% mHeart follow-up vs 35% conventional follow-up)[OR=3.4 (1.7;6.9),P-value=.001].

What next?

This eHealth experience has allowed continuing creating evidence on the use of the eHealth in other populations: an onco-hematological platform, EMMA(Ehealth Medical self-Management Aid), has been designed including diverse profiles depending on the clinical specifications (e.g. multiple myeloma or bone marrow transplant conditions); MyPlan has been adapted to perform an interdisciplinary follow-up of any multimorbid population with polypharmacy. Thus, the system can be used in any multimorbid patients by activating or omitting certain modules that define the target patients’ specific comorbidities (e.g. glycemia module or blood pressure module).
The new EMMA and MyPlan will be clinically tested in diverse trials in 2020 including several health care interdisciplinary teams, including the emergency setting, onco-hematology, migraine, dyslipidemia and cardiovascular risk, among relevant others. In addition, other Spanish centers are implementing the eHealth model and the software in their Institutions assisted by the experience gathered.

PANDEMIC CRISIS COVID 19: THE DRUGS HOME DELIVERY AS A TOOL FOR ADHERENCE AND COMPLIANCE

European Statement

Clinical Pharmacy Services

Author(s)

BARBARA RE, MARTA DEL VECCHIO, CLAUDIA LAURIA PANTANO, ELIROSA MINNITI , VITO LADISA

Why was it done?

The covid-19 pandemic and the lockdown made it difficult and very often not possible to access hospital pharmacies for dispensing of drugs for cancer treatment

What was done?

Drugs homedelivery has been implemented for fragile patients and at risk both oncological and hemato-oncological, all over the italian territory

How was it done?

Through the telemedicine program, in agreement with the oncologist, patients unable to reach the pathology doctor’s office are contacted and the project explained to them. If the patient accepts the delivery at home, paths with specialized couriers have been activated, in compliance with the GDPR, which ensure the delivery of medicines within 48 hours. Upon delivery The Pharmacist contacts the patient to ensure that they have been received the medicines and reinforces how you take the drug and the potential side effects that need to be reported to doctor and / or pharmacist

What has been achieved?

In the period from March to September 2020, 501 deliveries were made, of which 301 in the regional territory and 200 in the national territory. 423 patients were contacted, A Customer Satisfaction was activated to which 90% of patients with a high degree of acceptance of the service responded

What next?

The Homedelivery service has shown that integrating telemedicine, with the collaboration oncologist and pharmacist, allows, when possible, to avoid fragile patients having to go to the hospital every month to collect the drug needed for their treatment. Furthermore, the role of the pharmacist will be increasingly central in the home clinical management of this patient population to assure Adherence and Compliance even in at Home setting.

THE ADDITION OF A COST ANALYSIS CHANGES THE OUTCOME OF A TENDER (submitted in 2019)

Pdf

PDF Icon

European Statement

Introductory Statements and Governance

Author(s)

Camilla Munk Mikkelsen

Why was it done?

Including a CA in the evaluation is time-consuming and I wanted to evaluate whether the obtained drug recommendation was different from the result we could have achieved without the inclusion of a CA. The CA process includes data collection from clinicians within resource consumption per drug, including the costs of time usage of physician, nurse and patient, transportation expenses, monitoring costs, blood tests, co-medicine, utensils, shipping and hospital facilities. When a CA is included it is possible to take the derived costs associated with treatment of different drug dispensing forms and specific costs of treatment with various analogue drugs into account to achieve a recommendation upon the lowest total price including the tender price and the derived costs associated with the treatment.

What was done?

Tenders are made on ATC-level 5, but clinically equivalent therapeutic areas are evaluated on ATC-level 4. The analogue competition is an important strategic tool when conducting tenders and elaborating national recommendations on therapeutic areas (TA). Since 2017 the evaluation of TA has been based on a clinical evaluation, an economic evaluation and a tender. Previously the call for tenders was based on clinical evidence only. To evaluate whether the addition of a cost analysis (CA) to a tender evaluation would alter the drug recommendation of TA, a re-evaluation of the processed TA, evaluated from October 2018 until October 2019, was made on multiple sclerosis, rheumatoid arthritis and severe asthma.

How was it done?

The drug recommendations on TA made in the period was re-evaluated. Results from the cases with multiple sclerosis, rheumatoid arthritis and severe asthma were evaluated on clinical evaluation, tender price and finally with or without the CA.

What has been achieved?

From October 2018 to October 2019 three TA have ended the evaluation process. The recommendation of severe asthma had a similar outcome regardless of the process used. For multiple sclerosis and rheumatoid arthritis, the CA altered the drug recommendations.

What next?

In order to balance resource consumption on performing CA and the economic impact on the outcome, the plan is to identify TA where it isn’t meaningful to conduct a cost analysis. In all other areas a CA will be included in the standard procedures.

DEVELOPMENT OF AN INFORMATIC HAZARD VULNERABILITY ANALYSIS TOOL TO MINIMISE MEDICINES SHORTAGES (submitted in 2019)

Pdf

PDF Icon

European Statement

Selection, Procurement and Distribution

Author(s)

Daniele Leonardi Vinci, Enrica Di Martino, Rosario Giammona, Piera Polidori

Why was it done?

The 2018 Medicines Shortages Survey conducted by EAHP showed that 91% of responding pharmacists had experienced problems sourcing medicines, therefore it is important to use tools that identify early the shortage risk associated with each drug included in a hospital formulary in order to adopt appropriate countermeasures.

What was done?

We create an informatic HVA Tool (HVAT) to assess the risk associated with medicine shortage.

How was it done?

The HVAT created consists of an Excel spreadsheet subdivided into three macro areas: probability that the shortage will occur based on shortage in the last 2 years, magnitude factors which increase the risk of shortage, and mitigation factors which reduce it. A score was assigned to each item in each macro area. The score of the probability was: 1=no previous deficiency; 1.5=one deficiency; 2=two or more deficiencies. Magnitude was divided into: relevance of active substance (AS) (1= not life-saving and not High Risk Medicines (HRM); 2=not life-saving but HRM; 3=life-saving); budget impact (0=no alternative drug; 1=alternative drug costs equal to or less than the deficient one; 2=cost of the alternative drug higher than the deficient one but sustainable for all patients; 3=cost not sustainable for all patients); percentage of patients treated with the drug (1=less than 20%; 2=from 20% to 50%; 3=more than 50%). Mitigation factors were: therapeutic alternative (1=same AS and same route; 1.5=same AS and different route; 2=different AS and route not intravenous (IV); 2.5=different AS and route IV; 3=no alternative drug); stock available (1=for a month of autonomy; 2= autonomy between 1 week and one month; 3=autonomy less than 1 week); availability of the drug (1=drug available in EU; 2=drug available exclusively extra-EU; 3=drug not available).

What has been achieved?

The HVAT obtained allows us to calculate the value of the risk multiplying P by S, where P is the percentage of probability (value of probability obtained/2) and S is percentage of severity [(sum of values of magnitude obtained + sum of values of mitigation obtained)/18]. Based on the score obtained, drugs are classified as: low (60%) risk of shortage.

What next?

We will implement the HVAT in our hospital in order to reduce the impact of shortages.

PHARMACEUTICAL INTERVENTIONS IN PARENTERAL NUTRITION: METHODOLOGY AND RESULTS (submitted in 2019)

Pdf

PDF Icon

European Statement

Clinical Pharmacy Services

Author(s)

Teresa Cabeças, Sara Franco, Rita Oliveira, Maria Pereira

Why was it done?

PN is an alternative or complement in patients whose oral and/or enteral nutritional intake is inadequate/unsafe or whenever the digestive tract is not functioning or this route is contraindicated. Success in choosing the most appropriate PN depends on a specialised multidisciplinary team that can provide nutritional support that results in improved clinical outcomes and patient safety. With the decision flowchart (designed in January 2019), the hospital clinical pharmacist intervenes in the calculation of the patient’s nutritional needs and, consequently, in the counselling of the most appropriate PN bag and clinical and biochemical monitoring of the patient.

What was done?

Definition and implementation of action methodology, in a form of flow chart, for patients in need of parenteral nutrition (PN).

How was it done?

Implementation of the following therapeutic decision methodology: 1. Validation of parenteral support nutritional option according to decision flowchart; 2. Filling out a patient’s nutritional needs spreadsheet −anthropometric assessment; biochemical data; calculation of protein requirements; calculation of non-protein energy needs; calculation of total energy requirements; choosing the appropriate volume; validation of the route of administration; 3. Selection of the most suitable PN bag from the Hospital Formulary (preferably after ionic corrections); 4. PN bag suggestion to the prescribing physician; 5. Acceptance and alteration (or not) by the prescribing physician; 6. Clinical and biochemical monitoring of the patient; 7. Optimisation of nutritional therapy when applicable.

What has been achieved?

From January to August 2019 the Pharmaceutical Services intervened in all 21 PN prescriptions. In this universe, 15 were in the context of gastroenterology surgery, 5 due to infection and 1 due to non-gastrointestinal cancer disease. The intervention was not accepted in only 5 cases.

What next?

Clinical pharmacists play a key role in supporting the prescription of PN. The future is challenging, particularly in assessing patients’ outcomes and quality of life, as well as the economic and financial dimension. It will also be essential to create a Clinical Nutrition Commission that covers PN, enteral and oral feeding.

DEVELOPMENT OF GUIDELINES FOR SAFE HANDLING OF ONCOLYTIC VIRUSES (submitted in 2019)

Pdf

PDF Icon

European Statement

Clinical Pharmacy Services

Author(s)

Faten Ahmad Díaz, Eugenia Serramontmany Morante, Carla Esteban Sánchez, Pablo Latorre García, Montserrat Carreres-Prieto, Javier Martínez Casanova

Why was it done?

Different critical points were detected: 1) some OV dose prescription depends on tumor size, 2) special storage conditions, 3) special safety measures related to preparation to prevent cross-contamination and technician exposure, 4) special transport conditions in a safety container, and 5) safe administration. The increasing number of clinical trials with OV combined with the identified critical points implies a better coordination between the different departments involved.

What was done?

Development of a standardised working procedure for the safe handling considerations, storage requirements, and modes of administration of oncolytic viruses (OV) in patients with cancer.

How was it done?

Different meetings were arranged with a multidisciplinary team to standardise procedures, in order to avoid errors: 1. The pharmacist validates the prescription volume reflected on the certified sheet according to the tumour size. Then, a pharmacy technician is authorised to remove the vials from the freezer to start the preparation. 2. Special −80ºC freezer is needed to preserve the OV. 3. According to the preventive medicine service, OV must be prepared in biological safety cabinet class II (BSC) with personal protective equipment. At the end of preparation, the BSC must be cleaned with the OV appropriate disinfectant and ventilated for 1 hour before restarting to work again. So, the OV preparation was established at 7 a.m. in order to avoid cross-contamination with the chemotherapy (first preparation in the day). 4. Safety transport must be considered, so OV is packaged in a special hermetic box. 5. The majority of the OV preparations are administered intralesionally at the radiology room so safe administration is needed to avoid the room contamination.

What has been achieved?

By using these procedures, it is possible to work with a single BSC, avoiding delays in the administration of other therapies while reducing the risk of mistakes.

What next?

These types of therapies represent a novel therapeutic modality: their preparation, administration and handling requirements differ from current therapies; pharmacists have an important role in developing new procedures to incorporate them into clinical practice. This protocol may be useful to other centres due to the lack of experience and standardised guidelines to work with this type of therapy.